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NCT Number: NCT07191522

Efficacy of Photodynamic Therapy in the Non-Surgical Treatment of Peri-Implantitis

Peri-implantitis is a growing public health problem that can lead to several complications and sequelae, with a serious impact on the health and quality of life of patients and a high cost for healthcare systems.

Bacterial plaque that accumulates around dental implants leads to peri-implant tissue inflammation that ultimately can result in the loss of the implant, significant bone destruction and infection that can reach other regions. Successful implant decontamination is necessary to preserve the implant and several strategies have been suggested for this purpose, however, there is still no fully effective treatment modality and failures and recurrence are relatively frequent.

To better understand this problem and develop more effective treatment strategies, investigators will first conduct an epidemiological study to understand the factors associated with the development of this pathology. Although there is data at an international level, the incidence of this problem in Portugal has not yet been properly studied. Later investigators will conduct a randomized clinical trial to evaluate the 6-week clinical outcomes of patients treated with a photodynamic therapy as an adjuvant versus the use of conventional titanium implant curettes for implant surface decontamination in the non-surgical treatment. Sixty patients/implants with peri-implantitis and within the established criteria, will undergo non-surgical treatment with one of the two protocols being studied. Various clinical and radiographic parameters will be evaluated, such as probing depth, insertion loss, recession, bleeding on probing, suppuration, peri-implant crevicular fluid volume, alveolar bone loss and peri-implantitis microbiome will be evaluated before surgery and 6 weeks after surgery.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egas Moniz School of Health and Science

Almada, Monte Da Caparica, 2829-511, Portugal

Location status: Recruiting

Location contact

Inês Gomes, PhD

CONTACT

[email protected]

212946748 ext. 00351

Mariana A Assunção, Master

SUB_INVESTIGATOR

Mariana Assunção, Master

CONTACT

[email protected]

919970304 ext. 00351

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients over 18 years of age;
  • patients with one or more implants diagnosed with peri-implantitis rehabilitated for at least one year;
  • PI and GI < 25%.

Exclusion criteria

  • smoking patients;
  • patients with uncontrolled periodontitis;
  • systemic diseases that influence the study (diabetes);
  • inadequate prosthetic rehabilitation that cannot be modified or that prevents access for physical decontamination;
  • implants rehabilitated with cemented crowns;
  • pregnant and lactating women;
  • previous surgical intervention at the same site;
  • therapy with non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics or immunosuppressants in the last 3 months;
  • patients previously undergoing chemotherapy or radiotherapy;
  • PI and IG > 25%;
  • uncooperative patients.

Treatment and study plan

Mechanical debridment with titanium curettes and ultrasounds

Procedure

Removal of deposits above and below the gum line using hand or ultrasonic tools to reduce the inflammatory parameters

Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy)

Procedure

Non-invasive treatment that uses a combination of a light-sensitive compound (photosensitizer), specific light and oxygen to generate reactive oxygen species (ROS) that kill bacteria

Primary outcomes

  1. Probing Depth

    Time frame: From enrollment to the end of treatment at 3 months

    Measuring in milimeters the distance from the gingival margin to the base of a sulcus or peri-implant pocket, using a periodontal probe.

Secondary outcomes

  1. Clinical attachment level

    Time frame: From enrollment to the end of treatment at 3 months.

    Measured with a periodontal probe as the distance from a fixed reference point (usually the implant shoulder or gingival margin) to the base of the peri-implant pocket.

  2. Bleeding on Probing

    Time frame: From enrollment to the end of treatment at 3 months.

    Assessed during gentle probing; bleeding indicates a positive site.

  3. Suppuration

    Time frame: From enrollment to the end of treatment at 3 months.

    Detected by probing or gentle pressure, with purulent exudate confirming presence.

  4. Radiographic bone level

    Time frame: From enrollment to the end of treatment at 3 months.

    Assessed on standardized periapical radiographs, measuring the distance from a fixed reference point (implant shoulder or platform) to the most coronal bone-to-implant contact.

  5. Microbiology outcome

    Time frame: From enrollment to the end of treatment at 3 months.

    Changes in the microbiome collected from peri-implant pockets sequencing 16S ribosomal RNA gene

Study contacts

Contact information is provided by the study sponsor or research team.

Inês Gomes, PhD

CONTACT

[email protected]

212946748 ext. 00351

Mariana A Assunção, Master

CONTACT

[email protected]

+351919970304 ext. 00351

Sponsors and collaborators

Lead sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Other

Registry information

Acronym: PeriimpMAA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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